510(k) · Cleared
ClearedRemoval System Large Bore 60 cc Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inari Medical, Inc. · PUR Vacuum Syringe
Cleared on Mar 26, 2024 as substantially equivalent to K163597 (Merit Medical Systems, Inc., 2017) after a 182-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Mar 26, 2024
- Review
- 182 days
- Class
- Class II
- Product code
- PUR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K980580 (1998). No later device cites it as a predicate yet.
- Root · 4 generations backK980580 Becton Dickinson SyringesBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
- 3 generations backK024052 Merit Medical 1-ML SyringeMerit Medical Systems, Inc. · 2003
- 2 generations backK070936 Welmed Hypodermic SyringeWelmed, Inc. · 2007
- 1 generation backK163597 VacLok AT Vacuum SyringeMerit Medical Systems, Inc. · 2017
- This deviceK233069 Removal System Large Bore 60 cc SyringeInari Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K980580 | Becton Dickinson Syringes | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | — |
| −3 | K024052 | Merit Medical 1-ML Syringe | Merit Medical Systems, Inc. | 2003 | — |
| −2 | K070936 | Welmed Hypodermic Syringe | Welmed, Inc. | 2007 | — |
| −1 | K163597 | VacLok AT Vacuum Syringe | Merit Medical Systems, Inc. | 2017 | — |
| 0 (this device) | K233069 | Removal System Large Bore 60 cc Syringe | Inari Medical, Inc. | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PUR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K163597 | VacLok AT Vacuum SyringeSummary page 4…yringe Classification number 21 CFR 880.5860 Product code PUR Regulatory class II Predicate device(s) Merit VacLok AT Vacuum Syringe (K163597) Device description The Removal System Large Bore 60 cc Syringe is a general piston syringe co… | 2017 |
| † | K191368 | FlowTriever Retrieval/Aspiration System | 2019 |
| † | K231848 | Triever20 Curve (21-201) | 2023 |
| † | K231108 | Talon Transseptal Sheath | 2023 |
| † | K230494 | ClotTriever BOLD Catheter | 2023 |
| † | K191710 | FlowTriever Retrieval/Aspiration System | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All PUR devicesPUR Vacuum Syringe: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · PUR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PUR
Too few PUR 510(k)s in any year since 2007 to give a median.
Recalls per year · PUR
No recall names PUR since 2007.
Adverse event reports per year · PUR
No MAUDE report names PUR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Removal System Large Bore 60 cc Syringe is used with the Removal Catheters to inject fluids into or withdraw fluids and/or tissues from the body. It can be used for aspiration removal of fluid and/or tissue in the form of abscess fluid, infected materials, etc.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233069 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233069: Removal System Large Bore 60 cc Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233069
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026